Health Condition 1: D251- Intramural leiomyoma of uterus Health Condition 2: D250- Submucous leiomyoma of uterus Health Condition 3: D252- Subserosal leiomyoma of uterus Health Condition 4: null- Women with symptomatic fibroids
Conditions
Interventions
Intervention1: Mifepristone: 25mg/day for 3 months, orally
Control Intervention1: Mifepristone: 50 mg biweekly for 3 months, orally
Sponsors
Department of obstetrics and gynaecology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptomatic fibroid cases, measuring at least 3 cm exhibiting heavy menstrual bleeding or dysmenorrhoea or pelvic pressure 2. Those giving consent 3. Accepting the use of non-hormonal contraceptive 4. Agreeing to endometrial biopsy if needed
Exclusion criteria
Exclusion criteria: 1.currently planning pregnancy during study period 2.menopausal 3.currently breastfeeding 4.adnexal mass or endometriosis 5. coagulation dysfunction or bleeding tendencies 6.severe anemia 7.current or recent (within 3 months) use of oral / systemic corticosteroids or mifepristone 8.use within past 6 months of GnRH analogues 9.any contraindication to receive anti-progestins 10.any history or suspicion of breast cancer or other genital malignancy 11.laboratory findings that give any suspicion of blood, liver or renal dysfunction 12.those not giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibroid volumeTimepoint: 1.Before starting mifepristone 2.at end of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemoglobin levels 2. Improvement in pattern of periods and symptoms caused by fibroids. 3. Any side effects would be noted to study and compare the safety. Timepoint: 1.Before starting mifepristone 2.at end of 3 months | — |
Countries
India
Contacts
Public ContactDrNeelofar Shaikh
Government medical college and hospital
Outcome results
None listed